ARCHIVED — Vol. 146, No. 8 — April 11, 2012

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Registration

SOR/2012-65 March 30, 2012

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending the Food and Drug Regulations (Schedule to Part J — BZP and TFMPP)

P.C. 2012-345 March 29, 2012

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a), hereby makes the annexed Regulations Amending the Food and Drug Regulations (Schedule to Part J — BZP and TFMPP).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(SCHEDULE TO PART J — BZP AND TFMPP)

AMENDMENT

1. The schedule to Part J of the Food and Drug Regulations (see footnote 1) is amended by adding the following after item 19:

20. Benzylpiperazine [BZP], namely 1-benzylpiperazine and its salts, isomers and salts of isomers

21. Trifluoromethylphenylpiperazine [TFMPP], namely 1-(3-trifluoromethylphenyl)piperazine and its salts, isomers and salts of isomers

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations or the Order.)

Executive summary

Issue: The recreational use of benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) as an alternative to ecstasy poses a potential risk to the health and safety of Canadians. Effects associated with the use of products containing these substances include increased blood pressure, slowed breathing, hallucinations and seizures. As there is evidence that increasing volumes of these substances are being imported into Canada and that products containing BZP and TFMPP are becoming more widely available, Health Canada undertook an analysis to determine whether the substances should be regulated as controlled substances under the Controlled Drugs and Substances Act (CDSA).

Products containing BZP and/or TFMPP are readily available for purchase on the Internet (Canadian and non-Canadian sites) and in various alternative lifestyle stores. BZP has also been found in products marketed for use in weight loss. The sale of all such products is prohibited as both BZP and TFMPP meet the definition of a drug under the Food and Drugs Act (FDA) and no products containing these substances have been authorized for sale in Canada under the FDA.

In July 2008, in response to complaints received by the Health Products and Food Branch Inspectorate (Inspectorate), Health Canada issued an advisory regarding the sale of unapproved products containing BZP and TFMPP by the Canadian company Purepillz. Although the Department subsequently took enforcement action in the form of a stop sale notice, the company continued to sell these products across the country. Subsequent seizures at retail outlets and the company headquarters did not stop Purepillz from selling these products. As a result, early in 2011, charges were laid against Purepillz for unlawfully selling a number of drugs containing BZP contrary to the FDA. During the preliminary hearing for the case, the Court imposed a condition prohibiting the accused from possessing or distributing any of the drugs for which charges had been laid.

In December 2009, Health Canada issued a second advisory concerning BZP, warning consumers not to use “RevolutionDS Weight Loss,” an unauthorized health product containing BZP that was being sold as a weight loss aid.

To date, compliance and enforcement activities related to BZP and TFMPP have been carried out by the Inspectorate because the substances are not authorized for sale in Canada under the Food and Drugs Act. This regulatory amendment means that all future enforcement activities related to BZP and TFMPP will be carried out by law enforcement.

Description: The purpose of this regulatory amendment is to add benzylpiperazine (BZP), namely 1-benzylpiperazine and its salts, isomers and salts of isomers, and trifluoromethylphenylpiperazine (TFMPP), namely 1-(3-trifluoromethylphenyl)piperazine and its salts, isomers and salts of isomers, to Schedule III to the CDSA and to the Schedule to Part J of the Food and Drug Regulations (FDR-Part J). This will decrease the potential risks to health and public safety associated with the use and/or abuse of BZP and TFMPP by prohibiting activities with these substances, including possession, trafficking, possession for the purposes of trafficking, importation, exportation, possession for the purpose of exportation, and production, unless authorized by regulation. Inclusion in the Schedule to Part J will provide a means by which legitimate scientific and research activities involving these substances could be carried out in Canada, if required. This regulatory amendment is supported by the Royal Canadian Mounted Police (RCMP), the Canadian Association of Chiefs of Police (CACP), and the Canada Border Services Agency (CBSA).

Cost-benefit statement: This regulatory amendment will reduce the availability of BZP and TFMPP, benefitting Canadians by decreasing the potential health and safety risks associated with the use and/or abuse of these substances. Scheduling under the CDSA will also correct the misconception that BZP and TFMPP are safe for those currently engaged in activities with these substances and may prevent members of the general public from trying these substances. The costs to Health Canada are anticipated to be small given that there is already a licensing system for legitimate scientific and research purposes in place, and the amount of such research is not likely to be substantial. In addition, there will be a benefit to the Inspectorate as it will no longer need to allocate resources to compliance and enforcement activities related to BZP and TFMPP. Most importantly, law enforcement will benefit from having the tools they require to take action against suspected illegal activity.

Business and consumer impacts: This regulatory amendment is not expected to have any negative impact or impose an administrative burden on business as the only industry involved in handling these substances at present appears to be comprised of entities who import, manufacture and/or distribute BZP and/or TFMPP to consumers without authorization. In this regard, there is no legitimate industry to consider. Any persons conducting research with BZP and/or TFMPP will incur costs to ensure compliance with FDR-Part J; however, these costs will be minimal given that there are no fees associated with applying for this type of authorization. Consumers will benefit from the clear statement that BZP and TFMPP are not authorized by Health Canada for use in weight loss products, nor are they a safe alternative to ecstasy.

Domestic and international coordination and cooperation: In the development of this regulatory amendment, Health Canada has consulted with law enforcement and the CBSA. This regulatory initiative does not affect Canada’s international trade obligations as there is no legitimate trade in these substances. Many other countries, including the United States, Australia, and New Zealand, as well as the European Union, have already banned or elected to regulate BZP and/or TFMPP as controlled substances. The World Health Organization Expert Committee on Drug Dependence has also added BZP to its agenda for future scheduling assessments.

Issue

Benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) are used recreationally in Canada for their hallucinogenic and stimulant effects. Pills containing BZP and TFMPP have been marketed as a safe and legal alternative to 3,4-methylenedioxy-methamphetamine (MDMA), commonly known as ecstasy. BZP has also been found as an ingredient in products marketed for weight loss, despite the fact that such sale is prohibited. BZP and TFMPP meet the definition of a drug under the Food and Drugs Act (FDA) and therefore the sale, advertisement, or import for sale of these substances requires prior authorization from Health Canada. Compliance and enforcement measures under the FDA and FDR are the responsibility of the Health Products and Food Branch Inspectorate.

While the extent of their use in Canada is unknown, products containing BZP and TFMPP are available domestically for sale on the Internet and in various alternative lifestyle stores. In addition, both the RCMP and the CBSA have notified Health Canada of an increased volume of BZP and TFMPP being imported into Canada in recent years in both bulk raw powder and processed product forms. This is supported by the number of samples of drugs seized by law enforcement that were analyzed by Health Canada’s Drug Analysis Services and found to contain BZP and/or TFMPP, which has increased from 8 samples in 2006 to 2 559 samples in 2011.

The use of BZP and TFMPP poses a potential risk to the health of Canadians. Adverse effects associated with the use of these substances include increased body temperature, increased blood pressure, dilated pupils, increased euphoria, alertness, and paranoia. Taken together in high doses, BZP and TFMPP may cause hallucinations, slowed breathing and/or convulsions, and scientific evidence suggests these substances have a medium to high potential for abuse. BZP has been linked to such health effects as confusion, heart palpitations, agitation, anxiety, vomiting and seizures.

In 2007, concerned over reports of the abuse of and trafficking in piperazine-derived compounds, including BZP and TFMPP, the International Narcotics Control Board requested that the World Health Organization consider reviewing these compounds for possible scheduling under the 1971 Convention to which Canada is a signatory. The Board also urged governments to report any information on the emerging abuse of and trafficking in those substances. Although no scheduling action has occurred to date, a number of countries have already banned or elected to regulate BZP and/or TFMPP as controlled substances. For example, the United States, the European Union, New Zealand, Australia, Belgium and Denmark all regulate BZP as a controlled substance. New Zealand and Australia also regulate TFMPP as a controlled substance.

In July 2008, in response to complaints received by the Health Products and Food Branch Inspectorate, Health Canada issued an advisory regarding the sale of unauthorized products containing BZP by Purepillz. At the time of this advisory, the Department was conducting a risk assessment for BZP, which concluded that consideration should be given to regulating it as a controlled substance. As TFMPP is generally found in products that contain BZP, including those covered by the advisory, the Notice to interested parties that was subsequently published by Health Canada in November 2008 was not limited to BZP but rather included several piperazine derivatives with a view to seeking stakeholder input on whether some or all should be regulated under the CDSA. In December 2009, a second advisory concerning BZP was issued warning consumers not to use “RevolutionDS Weight Loss,” an unauthorized health product containing BZP that was being sold as a weight loss aid.

Objectives

The primary objective of this regulatory amendment is to protect the health and safety of Canadians by reducing the availability of two piperazine derivatives, BZP and TFMPP, in Canada by listing the substances in Schedule III to the CDSA. A secondary objective of this regulatory amendment is to enable access to BZP and TFMPP for legitimate scientific and research purposes, by adding the substances to the Schedule to Part J of the FDR.

Description

The CDSA provides a legislative framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual or to society when diverted or misused. The CDSA and its regulations also seek to support the legal manufacture of, trade in and possession of controlled substances for medical and scientific purposes.

Scheduling under the CDSA is a three-step process in that substances are first assessed as to whether or not they should be regulated under the CDSA and then into which Schedule they best fit. Finally, depending on whether they have a legitimate use (i.e. scientific, medical or industrial), a decision must be made regarding to which, if any, regulation the substances should be subject.

This regulatory initiative adds BZP and TFMPP to Schedule III to the CDSA, which means that all activities, including possession, trafficking, production, distribution, import and export, are illegal. Examples of other substances also listed in Schedule III include amphetamines, mescaline, flunitrazepam, and 4-hydroxybutanoic acid (GHB). (see footnote 2)

Part J of the FDR regulates the use of controlled substances that have no recognized medical use. Substances listed in the Schedule to Part J of the FDR are known as restricted drugs because they can be used only for scientific and research purposes. Scheduling BZP and TFMPP under Part J of the FDR establishes tight controls on activities involving these substances should they be used for scientific or research purposes, thereby minimizing the risk of diversion and misuse.

This regulatory amendment provides law enforcement agencies and the CBSA with the authority to take action against illegal activities involving BZP and TFMPP. Such actions could include the seizure of BZP, TFMPP and/or products containing these substances and the laying of drug charges against those conducting illicit activities with these substances in accordance with the CDSA.

The addition of

Benzylpiperazine (BZP) [1-benzylpiperazine] and its salts, isomers and salts of isomers; and

Trifluoromethylphenylpiperazine (TFMPP) [1-(3-trifluoromethylphenyl)piperazine] and its salts, isomers and salts of isomers

to Schedule III to the CDSA and the Schedule to Part J of the FDR and, consequently, the application of the regulatory provisions governing them will come into force upon registration. Health Canada will begin to accept applications for authorizations under Part J of the FDR immediately following registration of this regulatory amendment.

Regulatory and non-regulatory options considered

Option 1: Status quo. BZP and TFMPP are not regulated as controlled substances under the CDSA.

Option 1 was rejected as it does not sufficiently protect the health and safety of Canadians from BZP and TFMPP’s moderate to high potential for abuse, the potential risks to health associated with their use, and their increasing availability in Canada.

Option 2: BZP is added to one of the Schedules to the CDSA; TFMPP remains unscheduled.

The majority of products containing BZP also contain TFMPP to achieve a more desired level of effect. Accordingly, if not controlled under the CDSA, TFMPP could be used as a replacement for BZP, thereby diminishing the benefits to the health and safety of Canadians that would be achieved through control of BZP under the CDSA. This option was therefore rejected. In addition, although this option would be consistent with some jurisdictions (e.g. the United States), it would be inconsistent with others that are regulating TFMPP (e.g. New Zealand and Australia).

Option 3: BZP and TFMPP are added to Schedule IV to the CDSA.

Adding BZP and TFMPP to Schedule IV would mean that all activities with these substances (e.g. distribution, import, export) except simple possession would be illegal. Option 3 was, however, rejected because it would not effectively reduce the availability of BZP and TFMPP or reduce the potential health risks associated with their consumption. In addition, the absence of an offence for possession is inconsistent with the control mechanisms in place in the European Union and other countries, including New Zealand, Australia and the United States. In addition, BZP and TFMPP are not pharmacologically similar to substances listed in Schedule IV.

Option 4: BZP and TFMPP are added to Schedule III to the CDSA; no authorized use is permitted by regulation.

Adding BZP and TFMPP to Schedule III would mean that all activities with these substances, including possession, would be illegal. These control measures would address the increasing availability of BZP and TFMPP in Canada and the associated risk to the health and safety of Canadians. BZP and TFMPP are known stimulants, as are the majority of substances currently listed in Schedule III to the CDSA. Option 4 would also be consistent with the control measures imposed in other countries such as New Zealand and the European Union.

While there are no known medical or other legitimate uses for BZP and TFMPP in Canada, there is potential that these substances could be used for scientific research. Option 4, although it provides an appropriate level of control of BZP and TFMPP, lacks a means by which legitimate scientific research could be carried out in the future, if required, and was therefore rejected.

Option 5: BZP and TFMPP are added to Schedule III to the CDSA and regulated under Part J of the Food and Drug Regulations.

This option seeks to add BZP and TFMPP to Part J of the FDR. These Regulations allow people to be authorized to import, export, produce, make, assemble, sell, provide and/or transport BZP and TFMPP for the purposes of scientific research.

Option 5 was the recommended option because it provides an appropriate level of control for BZP and TFMPP. It adequately addresses the risk their availability poses to Canadians by making all activities with these substances illegal except those associated with legitimate research as regulated under Part J of the FDR.

Benefits and costs

Health Canada commissioned a market analysis in order to examine the availability, distribution and pricing of BZP, TFMPP and/or products containing these substances in Canada. Although limited data on factors such as consumption and price were obtained, Health Canada reached certain conclusions about the domestic situation using existing databases, experts and the Internet, most notably the steady increase in availability in recent years, which in turn provide a basis for a qualitative analysis of benefits and costs.

This regulatory amendment may affect Canadians, particularly those who are currently or may become engaged in activities with BZP and TFMPP (e.g. sale, import, export), as well as Health Canada, the Canada Border Services Agency, and law enforcement. There are three primary groups of Canadians that may be affected:

those who use BZP, TFMPP, or unauthorized products containing these substances for such claims as weight loss (consumers);

those who use BZP, TFMPP or products containing these substances for recreational purposes (users); and

those who do not consume BZP, TFMPP or products containing these substances but who may be affected indirectly by their availability and/or use (general public).

Benefits

Adding BZP and TFMPP to Schedule III to the CDSA means that all activities with these substances will be illegal. This is expected to reduce the availability of these substances and products containing these substances considerably because the penalties for illegal activities involving substances included in Schedule III to the CDSA are significant, (e.g. imprisonment up to 3 years for possession, imprisonment up to 10 years for trafficking). This reduced availability is expected to yield public safety, health and financial benefits.

Public safety

For consumers and users of BZP, TFMPP and/or products containing these substances, scheduling under the CDSA indicates that these substances are not safe when taken for purposes such as weight loss or as an alternative to ecstasy and clearly establishes that they cannot be bought or sold. Scheduling may also prevent some members of the general public from trying these substances for the first time as well as mitigate the public safety issues associated with the sale of products containing these substances by providing law enforcement with tools to take action against suspected illegal activity.

Health

Decreasing the availability of substances that are taken for their stimulant and hallucinogenic effects (e.g. BZP and TFMPP) has been shown to effect a corresponding decrease to the potential health and safety risks associated with their use. This is supported by research conducted in New Zealand that showed that regulatory action such as scheduling as a controlled substance leads to

a reduction in the number of recreational users;

a potential decrease in the number of emergency room visits per recreational user; and

reduced negative health impacts associated with treating the adverse effects linked to consumption of these substances.

Financial

For all Canadians, reducing the availability of BZP and TFMPP may reduce the financial burden on the health care system associated with treating the adverse side effects associated with use and/or abuse of these substances.

Costs

Industry

There are no known legitimate uses for BZP and TFMPP in Canada; thus, there is no known legitimate industry to consult in terms of identifying cost impacts associated with scheduling BZP and TFMPP under the CDSA.

Financial

There is no mechanism for consumers and users to be compensated for costs they may have incurred while engaging in activities related to BZP and/or TFMPP or costs that they may incur should they be charged with an offence under the CDSA.

Costs to Health Canada resulting from this regulatory amendment are expected to be minimal and absorbed by existing programs. For example, the operational costs associated with authorizing the use of BZP and TFMPP for scientific and research purposes, if required, are anticipated to be small given that there is already a licensing system in place for this purpose, and the amount of such research is not likely to be substantial. In addition, there will be a benefit to the Inspectorate as it will no longer need to allocate resources to compliance and enforcement activities related to BZP and TFMPP.

This regulatory amendment will result in costs to law enforcement in investigating, charging and prosecuting offences under the CDSA related to BZP and TFMPP, and the extent of these costs are unknown.

Costs to the CBSA in implementing this regulatory amendment are expected to be minimal as the CBSA is already engaged in enforcement activities related to BZP and TFMPP under the authority of the FDA.

Rationale

Adding BZP and TFMPP to Schedule III to the CDSA means that all activities with these substances will be illegal, thereby reducing their availability in Canada and providing the greatest benefit in terms of protecting the health and safety of Canadians. The potential health and abuse risks of these substances and evidence of their increasing availability in Canada warrant these control measures. Adding BZP and TFMPP to the Schedule to Part J of the FDR provides an appropriate mechanism for controlled access to these substances for legitimate scientific or research purposes, should this be required at some point in the future.

Regulating BZP and TFMPP as controlled substances is also consistent with ongoing discussions at the international level regarding the scheduling of BZP under the 1971 United Nations Convention on Psychotropic Substances. Should such a decision be taken internationally, Canada would be obligated to follow suit as it is a signatory to that Convention.

Consultation

Health Canada first published a Notice to interested parties in the Canada Gazette, Part Ⅰ, on November 22, 2008, with a view to seeking stakeholder input on whether eight piperazine derivatives, including BZP and TFMPP, should be regulated as controlled substances under the CDSA. The Notice also sought to determine the presence of any legitimate activity involving these substances and to identify stakeholders interested in the proposed scheduling action.

During the 30-day comment period following publication, five submissions were received. Notably, no organizations presented any evidence that the substances were being used for legitimate purposes, such as pharmaceutical research or any other industrial purpose.

Two submissions dealt with how the substances would be classified when scheduled under the CDSA. It was suggested that the term “isomers and salts of isomers” be included in the schedule entry for TFMPP for easier identification of the substance when performing lab analyses. One submission sought information on what to do with products containing BZP and/or TFMPP should the substances be scheduled under the CDSA. Since all activities with BZP and TFMPP, including possession, trafficking, production, distribution, import and export will be illegal upon registration of this regulatory amendment, Health Canada advises persons in possession of these substances or any controlled substance to seek legal advice if they have questions about compliance.

The remaining submissions expressed negative reactions to Health Canada’s intent to regulate BZP and TFMPP under the CDSA. Specifically, concern was expressed regarding the potential impact on the criminal justice system and the claim was made that reducing access to BZP and TFMPP would lead to increased use of other more harmful stimulant drugs.

Health Canada elected to publish a second Notice to interested parties on January 21, 2012, in the Canada Gazette, Part Ⅰ. The Notice invited comments on the proposal to add two of the eight piperazine compounds listed in the original Notice, specifically BZP and TFMPP, to Schedule III to the CDSA and the Schedule to Part J of the FDR. One submission was received in response to this Notice seeking information regarding the process Health Canada follows in scheduling substances under the CDSA. It also questioned drug control policy issues that are beyond the scope of this regulatory amendment.

Law enforcement, including the RCMP and the Canadian Association of Chiefs of Police as well as the Canada Border Services Agency, have indicated their support for this regulatory amendment.

Implementation, enforcement and service standards

Health Canada will notify stakeholders (e.g. law enforcement, provincial/territorial ministries of health, provincial/territorial licensing authorities for medicine and pharmacy and the research community) of this regulatory amendment and provide relevant links on the Department’s Web site.

Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA or its Regulations. Criminal prosecution for offences under the CDSA or in relation to a contravention of the CDSA may involve the application of a fine and/or a term of imprisonment. This is the responsibility of the criminal justice system.

Health Canada will be responsible for assessing any incoming requests for permission to conduct research involving BZP and/or TFMPP and for monitoring compliance with Part J of the FDR.